A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
ConditionDengue Fever
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-20
SponsorTakeda
About this trial
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant is aged >=6 to <21 months at the time of entry into the trial.
Participant is male or female.
Participant is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
Disqualifiers
Participant has contraindication(s), warning(s) and/or precaution(s) applicable to vaccination with TDV as specified in the investigator's brochure (IB)and/or the approved product label (as applicable) in the participating country.
Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
Trial design
Design model
Sequential
Treatments tested in this trial
TDV
Biological/VaccineTDV SC injection.
Placebo
Other interventionPlacebo SC injection.
Treatment groups
212 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months)Experimental treatment 1 intervention
Group B: Cohort 1: Placebo (Age group: >=12 to <21 months)Experimental treatment 1 intervention
Group C: Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months)Experimental treatment 1 intervention
Group D: Cohort 2: Placebo (Age group: >=6 to <12 months)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity)
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame
Within 7 Days post-vaccination at Day 12
Percentage of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame
Within 7 days post-vaccination at Day 903
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)
Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38-degree Celsius \[C\], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame
Within 14 days post-vaccination at Day 14
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)
Solicited systemic AEs include fever (body temperature \>= 38 degree (C), drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame
Within 14 days post-vaccination at Day 90Secondary outcomes
1
GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes
GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame
Day 1, Day 30, Day 270, Day 450, Day 810 and Day 11702
Seropositivity Rates for 4 Dengue Virus Serotypes
Seropositive rate is defined the percentage of participants with MNT titer \>=10 against each of the four dengue virus serotypes. The four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.
Time frame
Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 11703
Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes
Seropositive rate is defined the percentage of participants with MNT titer \>=10 against multiple (2, 3, or 4) dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame
Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170 Source ClinicalTrials.gov